Transcript SO-III TCT 2008

SORT-OUT III: A Prospective Randomized
Comparison of Zotarolimus-Eluting and
Sirolimus-Eluting Stents in Patients with
Coronary Artery Disease
Michael Maeng, Klaus Rasmussen, Per Thayssen,
Henning Kelbæk, Jan Ravkilde, Ulrik Abildgaard, Lisette
O. Jensen, Evald H. Christiansen, Knud N. Hansen,
Hans-Henrik Tilsted, Peter R. Hansen, Lars R. Krusell,
Thomas Engstrøm, Jens Aarøe, Jan S. Jensen, Hans E.
Bøtker, Steen D. Kristensen, Steen Z. Abildstrøm, Anne
Kaltoft, Morten Madsen, Søren P. Johnsen, Henrik T.
Sørensen, Leif Thuesen & Jens F. Lassen
SORT-OUT III: A Prospective Randomized
Comparison of Zotarolimus-Eluting and
Sirolimus-Eluting Stents in Patients with
Coronary Artery Disease
Conflicts of interests for Michael Maeng, M.D.
Cordis, Johnson & Johnson:
Speaker fees
Medtronic:
Consultant fee
Background
• Three published studies (Endeavor III, ISARTEST-2, ZEST-AMI) have shown that the
zotarolimus-eluting Endeavor stent (END) is
inferior to the sirolimus-eluting Cypher stent
(CYP) with regard to angiographic endpoints None of these studies were powered to
assess clinical endpoints
Purpose
To compare the clinical outcome in routine
clinical care (“all-comer”) patients randomized
to Endeavor or Cypher stent implantation
PCI Organization in Denmark
PCI center
Population of 5,5 million inhabitants
5 high volume PCI centers
12-month dual anti-platelet therapy
is recommended
100 US miles
Methods
• The study was performed within the framework of
the Danish Organization for Randomized Trials
with Clinical Outcome (SORT OUT)
• We designed the study to reflect daily clinical
practice. Therefore, no control angiography or
study-related patient contact were scheduled
• We used patient driven clinical event detection
by use of the Danish Civil Registration system, the
National Patient Registry, and the Danish Heart
Registries
Methods
Inclusion: Indication for treatment with a DES
Exclusion: Inability to provide informed consent
Life expectancy < 1 year
Allergy to aspirin or clopidogrel
Participation in another trial
Endpoints
Primary endpoint:
Major adverse cardiac events (MACE)
defined as a composite of cardiac
mortality, myocardial infarction (MI), or
target vessel revascularization (TVR)
Secondary endpoints:
All cause mortality
Cardiac mortality
MI
Definite stent thrombosis (ARC definition)
TVR
Target lesion revascularization (TLR)
Results
• 2,332 patients were enrolled
• Complete 18-month follow-up in 2,200
(94%) patients
Selected Patient Characteristics
No of patients
Age (yrs)
END
1162
64
CYP
1170
64
Male (%)
Diabetes (%)
Hypertension (%)
Lipid-lowering therapy (%)
73
15
54
70
72
14
51
68
Previous CABG (%)
Previous PCI (%)
7
21
7
17
Previous MI (%)
26
27
PCI Indication
END
CYP
Stable angina (%)
NSTEMI/UAP (%)
53
38
51
38
STEMI (%)
Other (%)
6
4
9
3
Selected Lesion Characteristics
END
CYP
No of lesions/patient
1.6
1.5
Stents/patient
1.8
1.7
Lesion length (mm)
13
14
Stent length (mm)
18
18
Stent diameter (mm)
3.2
3.2
Lesion type A (%)
20
18
Lesion type B (%)
45
48
Lesion type C (%)
36
35
MACE
HR = 2.19 (1.58 – 3.04)
P < 0.0001
END : 9.7%
CYP : 4.5%
All Cause Mortality
HR = 1.61 (1.03 – 2.50)
P = 0.035
END : 4.4%
CYP : 2.7%
Cardiac Death
HR = 1.51 (0.73 – 3.14)
P = 0.27
END : 1.6%
CYP : 1.0%
Myocardial Infarction
HR = 2.22 (1.09 – 4.53)
P = 0.029
END : 2.1%
CYP : 0.9%
Definite Stent Thrombosis
HR = 2.19 (0.83 – 5.77)
P = 0.13
END : 1.1%
CYP : 0.5%
Target Vessel Revascularization
HR = 2.42 (1.67 – 3.52)
P<0.0001
END : 7.9%
CYP : 3.3%
Target Lesion Revascularization
HR = 3.66 (2.23 – 6.01)
P < 0.0001
END : 6.1%
CYP : 1.7%
Conclusion
The Endeavor stent was inferior to the
Cypher stent in routine clinical care (“allcomer”) patients at 18-month follow-up
For further details …..
The SORT OUT III 18-month manuscript is
published on-line in The Lancet today
Thank you for your attention